Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT06964802

The Effect of Cold Salt Water Foot Bath on the Development Of Chemotherapy-Induced Peripheral Neuropathy

Led by Tuba Eryiğit · Updated on 2026-04-16

30

Participants Needed

1

Research Sites

56 weeks

Total Duration

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AI-Summary

What this Trial Is About

This prospective, randomised, controlled study was designed to evaluate the effectiveness of salt and unsalted cold water foot baths in preventing chemotherapy-induced peripheral neuropathy (CIPN) in patients receiving paclitaxel. The study's sub-objectives were to minimise the development of CIPN, reduce its severity and incidence of symptoms, and minimise its impact on daily life and activities. Hypothesis(es): H1: Salt cold water foot bath affects the development of chemotherapy-induced peripheral neuropathy. H2: There is an effect of unsalted cold water foot bath on the development of chemotherapy-induced peripheral neuropathy. H3: The effects of salt and unsalted cold water foot baths on the development of chemotherapy-induced peripheral neuropathy. H4: Salt and unsalted cold water foot baths are more effective than standard clinical care in the development of chemotherapy-induced peripheral neuropathy. Researchers will compare the salt cold water with the unsalted cold water, unsalted cold water and control group to determine whether the salt cold water has an effect on CIPN. The experimental group and active comparator participants will continue the application for 12 cycles (12 weeks) of paclitaxel. The application will be applied by researcher Tuba Eryiğit. In addition, before each application for 12 weeks, the severity of CIPN, its effect on daily life and grade will be evaluated. The control group will continue clinical routine care applications for 12 cycles (12 weeks). In addition, the severity of CIPN, its effect on daily life and grade will be evaluated before each treatment in the same way as the experimental groups.

CONDITIONS

Official Title

The Effect of Cold Salt Water Foot Bath on the Development Of Chemotherapy-Induced Peripheral Neuropathy

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 and over
  • Conscious
  • Able to speak and understand Turkish
  • Diagnosed with breast cancer
  • Scheduled to receive paclitaxel chemotherapy
  • No symptoms of peripheral neuropathy as indicated by a negative response to section 'A' of the CIPNAT scale
Not Eligible

You will not qualify if you...

  • Abnormal vibration test results indicating existing neuropathy
  • Reduced sensation in one or more areas on the sole of the foot by monofilament test
  • Previous chemotherapy-associated peripheral neuropathy
  • Diagnosed with diabetes
  • Presence of open wounds or skin ulcers on the feet
  • Peripheral or central nervous system diseases
  • Peripheral vascular disease
  • Bone or soft tissue metastases

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Trial Site Locations

Total: 1 location

1

Haydarpaşa Numune Training and Research Hospital

Istanbul, Uskudar, Turkey (Türkiye), 34668

Actively Recruiting

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Research Team

T

Tuba Eryigit, PhD student

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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